ENSEMBLE
Research type
Research Study
Full title
A single-arm extension study to investigate the long-term safety, tolerability, and efficacy of lunsekimig in adult participants with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) who completed a previous lunsekimig CRSwNP clinical study
IRAS ID
1011485
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2024-515912-27
Research summary
Chronic Rhinosinusitis with Nasal Polys (CRSwNP) is a condition where Nasal Polyps (abnormal lumps) may form inside the nose of patients with long-term swelling (inflammation) of this area. Current treatment aims to reduce swelling and symptoms using treatments such as steroid nasal sprays and steroid pills. However, many people continue to have symptoms that interfere with their daily lives and better medicines are needed for extended use.
The purpose of this study is to determine the safety of Lunsekimig long term use for reducing the signs and symptoms of chronic rhinosinusitis. This open-label, single-arm study includes 52 weeks of treatment. This is given as a solution for injection, under skin of abdomen, thigh, or upper arm, for all eligible participants and includes 13 treatment / injection visits for each participant. If agreed, and available, some treatments may be given at a participants home.
Open-label means that the participants and researchers both know which treatment is given and single arm confirms that there is no placebo and only active treatment with Lunsekimig. Treatment for all participants will also include nasal steroid sprays at predetermined periods during the 52 weeks of treatment.
Early studies of Lunsekimig have suggested potential benefit by reducing the type of inflammation that can cause chronic rhinosinusitis with nasal polyps. There are no identified risks associated with Lunsekimig, except for the rare risk of having an allergic reaction.
All eligible participants who complete treatment will undergo a follow-up period of 4 weeks to monitor the participants for any side effects.
Participants are considered eligible if they are Adults with chronic rhinosinusitis with nasal polyps and continued symptoms who had previously completed another Lunsekimig (CRSwNP) clinical study.REC name
London - Riverside Research Ethics Committee
REC reference
25/LO/0091
Date of REC Opinion
8 Apr 2025
REC opinion
Further Information Favourable Opinion